Design Assurance Engineer

Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

We are looking for a Design Assurance Engineer to join us in our mission. This role is based in our facility in Ballinasloe, Co . Galway and offers a 4 day condensed working week, inclusive of Monday to Thursday.  One year fixed term Temporary contract. 

Overview

The Design Assurance Engineer is a key member of the Quality team charged with establishing, implementing and maintaining the Quality System on site.

Responsibilities

• Provide direction and guidance to projects team from a Quality and regulatory perspective.
• Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.
• Summarises, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
• Partner with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
• Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality.
• Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
• Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards.
• Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
• Ensure project timelines are achieved in relation to regulatory submissions and quality related activities.
• Ensure adoption and implementation of the integrated QMS.
• Supports the Customer Complaint and Post Market Surveillance programs.

Qualifications

• An Engineering or Quality Assurance Degree or equivalent experience.
• A minimum of 3 years post qualification experience as a Design Assurance Engineer within a Medical Device or regulated environment.

Competencies and Attributes

• Strong working knowledge of the product development process within the medical device industry.
• Detailed knowledge of the regulatory environment in which the business operates including FDA, European, and other International Regulatory requirements.
• Ability to support and lead DA activities on multiple projects simultaneously.
• Strong technical writing and verbal communication skills.
• A good team player who works effectively both on their own and with peers from cross functional team members.
• Strong interpersonal / communication skills, with ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
• An analytical approach to problem solving.
• Is creative, continually learning and exploring new ideas.
• A self-starter who applies his/her own initiative in most situations.
• Capacity to make sound judgements while learning from mistakes.
• Attention to detail while maintaining awareness of longer-term objectives.
• Displays the highest levels of integrity.
• Capacity to maintain the highest levels of confidentiality internally and externally.
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Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, medical insurance. Life assurance cover, Recognition Awards. 

 Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.